Basic↦Drug or Device↦Medical Device↦Manufacture Responsibility
What is it? Why is it important?
A manufacturer who puts a Medical Device (MD) on the market (e.g. EU) carries full responsibility for its ongoing safety and error-free performance.
Responsibilities include:
- MD Registration: the manufacturer
- Assigns the MD with a unique identifier
- Registers the MD (e.g. Swissdamed, Eudamed)
- MD technical documentation: the manufacturer manages and keeps technical documents up-to date allowing access to:
- MD conformity assessments
- Post-market surveillance data
- Implementation of a risk-based quality management system: the manufacturer implements risk management procedures that include the:
- Management of a post-market surveillance system
- Execution of preventive and corrective measures in the event adverse events / device deficiency occurrences
The Federal Council
- Defines registration and identification modalities
- Specifies which technical information and data to document, and how the documentation is made available.
More
The management of the MD vigilance and surveillance system:
Swissmedic is responsible for the management of the system`s database, that include:
- Access rights
- Technical measures to ensure data protection and data security
- Data archiving requirements
Swissmedic screens the data with the aim to ensure ongoing MD safety. In the event of adverse events (e.g. SAE, SDE, DD), Swissmedic will contact the marketing holder in order to implement risk control-measures.
Swissmedic is also responsible for the authorisation and notification procedures regarding MD conducted studies
What do I need to do?
As a SP-INV, make yourself familiar with manufacturer responsibilities and how it relates to responsibilities regarding Medical Devices in the setting of a study.
Where can I get help?
Your local Research Support Centre↧ can assist you with experienced staff regarding this topic
Basel, Departement Klinische Forschung (DKF), dkf.unibas.ch
Lugano, Clinical Trials Unit (CTU-EOC), ctueoc.ch
Bern, Department of Clinical Research (DCR), dcr.unibe.ch
Geneva, Clinical Research Center (CRC), crc.hug.ch
Lausanne, Clinical Research Center (CRC), chuv.ch
St. Gallen, Clinical Trials Unit (CTU), h-och.ch
Zürich, Clinical Trials Center (CTC), usz.ch
External Links
Swissmedic – see in particular
- About us / publications / Swissmedic videos / about Medial Device (MD)
- Medical Device / Market Surveillance
- Medical Device / swissdamed – Swiss database in medical devices
- Medical devices / regulation of medical devices / Information form the European environment
Swiss Law
TPA – see in particular articles
- Art. 4 Medical Device (MD) definition
- Art. 47109 Registration and device identification
- Art. 47a110 Documentation requirements
- Art. 47b111 Quality management
- Art. 26 Principle of prescription, dispensing and application
- Art. 48 Dispensing and use
- Art. 62c151 Medical devices information system
MedDO – see in particular
- Chapter 7 Device surveillance